Triple Negative Breast Neoplasms
Recent clinical, regulatory, research and industry developments relating to this disease.
Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer.
Recent progress in immune evasion mechanisms of triple-negative breast cancer.
Biomarkers of response and resistance to immune checkpoint inhibitors in breast cancer.
Window of opportunity trials with immune checkpoint inhibitors in triple-negative breast cancer.
Liquid biopsy in triple-negative breast cancer: unlocking the potential of precision oncology.
Immunotherapy in Breast Cancer.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 3 clinical trials expected to report results, the earliest in Q4 2027.
- Active recent publication activity, including 1 notable finding.
- Q4 2027A Multicenter Single Arm Phase II Study With Bicalutamide in Combination With Abemaciclib in 4 Cohorts of Locoregionally Advanced Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
- Q3 2028A Phase II Study to Evaluate CAPecitabine Plus Pembrolizumab as Post-operative Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Chemo-immunotherapy
- Q2 2030A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)
Research HighlightsViewHide
- 2026-01-01Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer.Tolaney SM · 2026
- 2025-11-18Recent progress in immune evasion mechanisms of triple-negative breast cancer.Yang Y · 2025
Clinical MilestonesView all 11Hide
- 2026-03-03An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009)Results posted
- 2025-12-12Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast CancerResults posted
- 2025-11-12A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast CancerResults posted
- 2026-07-20A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)Results expected Q2 2030
- 2026-04-01A Multicenter Single Arm Phase II Study With Bicalutamide in Combination With Abemaciclib in 4 Cohorts of Locoregionally Advanced Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast CancerResults expected Q4 2027
- 2025-11-17A Phase II Study to Evaluate CAPecitabine Plus Pembrolizumab as Post-operative Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Chemo-immunotherapyResults expected Q3 2028
- 2026-03-16A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.Primary completion
- 2025-10-14A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)Completed
- 2025-10-09Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab: A Phase III Randomized Trial. Sponsor: Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, Università di PadovaCompleted
- 2026-02-05A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA MutationTerminated
- 2025-09-30Phase II Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast CancerTerminated
- 2026-07-20ClinicalA Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)Results expected Q2 2030
- 2026-04-01ClinicalA Multicenter Single Arm Phase II Study With Bicalutamide in Combination With Abemaciclib in 4 Cohorts of Locoregionally Advanced Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast CancerResults expected Q4 2027
- 2026-03-16ClinicalA Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.Primary completion
- 2026-03-03ClinicalAn Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009)Results posted
- 2026-02-05ClinicalA Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA MutationTerminated
- 2026-01-01ResearchSacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer.Tolaney SM · 2026
- 2025-12-12ClinicalSingle Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast CancerResults posted
- 2025-11-18ResearchRecent progress in immune evasion mechanisms of triple-negative breast cancer.Yang Y · 2025
- 2025-11-17ClinicalA Phase II Study to Evaluate CAPecitabine Plus Pembrolizumab as Post-operative Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Chemo-immunotherapyResults expected Q3 2028
- 2025-11-12ClinicalA Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast CancerResults posted
Research-associated treatments
Drugs and agents co-studied with this disease across the research literature — associative, not necessarily established treatments. Number shows shared papers.
Clinical trials
The current development programme across all trial phases.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes8
- Triple Negative Breast Neoplasms46
- Breast Neoplasms8
- Antibodies, Monoclonal, Humanized7
- Immunoconjugates7
- Immune Checkpoint Inhibitors5
- Antineoplastic Agents3
- Antineoplastic Combined Chemotherapy Protocols3
- Antigens, Neoplasm2
Leading journals6
- Nature communications6
- The New England journal of medicine6
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology5
- Annals of oncology : official journal of the European Society for Medical Oncology2
- Breast (Edinburgh, Scotland)2
- Clinical cancer research : an official journal of the American Association for Cancer Research2
Leading researchers8
- Schmid P10
- Rugo HS8
- Loi S7
- Barrios CH6
- Adams S5
- Diéras V5
- Im SA5
- Iwata H5
Affiliations (unnormalised)6
- Dana-Farber Cancer Institute9
- Barts Cancer Institute4
- Massachusetts General Hospital4
- Baylor University Medical Center3
- Institut Curie3
- Institut Jules Bordet3
Disease biology
Key proteins & gene products studied in this disease. Number shows shared papers.
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Triple-negative breast neoplasms are breast cancers that do not express estrogen receptor or progesterone receptor and do not overexpress HER2. They are described as a particularly aggressive and heterogeneous subtype with high invasiveness, metastatic potential, frequent relapse, and poor prognosis.
The supplied grounding does not support a single established cause or aetiology for triple-negative breast neoplasms. The literature instead emphasizes molecular heterogeneity and specific mutations or aberrant pathway activation in subsets of tumors.
The disease is characterized by loss of ER, PR, and HER2 expression, which removes responsiveness to endocrine and anti-HER2 approaches. The literature also links its biology to altered signaling pathways, tumor microenvironment interactions, drug resistance, cancer stem cells, and mechanisms of tumor escape, with specific attention to DNA repair, Wnt signaling, and immune checkpoint-related pathways.
The supplied grounding does not provide general patient-level risk factors for developing triple-negative breast neoplasms. It does note that some treatment-relevant subgroups include PD-L1-positive tumors and germline BRCA-mutated tumors.
Chemotherapy remains the standard of care, with surgery and radiotherapy also used in current treatment approaches. Because these tumors do not respond to endocrine therapy or HER2-targeted therapy, treatment development has focused on chemotherapy, immune checkpoint inhibitors, PARP inhibitors for selected BRCA-mutated disease, and other targeted therapies such as agents directed at DNA repair pathways, kinase signaling, and related molecular subtypes.
AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
Breast neoplasms that do not express ESTROGEN RECEPTORS; PROGESTERONE RECEPTORS; and do not overexpress the NEU RECEPTOR/HER-2 PROTO-ONCOGENE PROTEIN.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.